23andMe

And the FDA

A regulator brings a genetics company to a halt

THE Food and Drug Administration had been kept waiting long enough. On November 22nd the FDA, America’s public-health regulator, sent a stern letter to 23andMe, a genetic-testing firm. Despite “more than 14 face-to-face and teleconference meetings, hundreds of e-mail exchanges and dozens of written communications”, the FDA complained, the company had not met its requests for data—nor even contacted it since May. The FDA ordered 23andMe to stop selling its testing service forthwith. The company has 15 days to respond to the regulator’s concerns. Fights over genetic testing, however, are sure to go on for a lot longer.

It used to be that patients learned about their health only from their doctor. Thanks to mobile health gadgets, apps and services such as 23andMe’s, that is changing. Since 2007, 23andMe has invited its customers to spit into a tube, send it back to the company and thus learn the secrets of their genome—or, at least, the aspects of it that 23andMe tests. The company is a Silicon Valley favourite, led by Ann Wojcicki, wife of Sergey Brin, one of Google’s founders. Its backers include Google and Yuri Milner, a billionaire investor in Facebook and Twitter.

Ms Wojcicki maintains that people have a right to their genetic information. The FDA is more cautious. It says that telling people about their genome is all well and good, but because 23andMe’s tests might be used to make medical decisions, the agency must verify their accuracy. In its letter to the company, the FDA said that inaccurate information about a gene linked to breast cancer could lead a woman to have unnecessary surgery.

The company applied for FDA approval last year. Regulators asked for more information, but the agency says 23andMe did little to gather it. Meanwhile, the company pressed on with other plans. In the past year the firm has lowered the price of its tests to $99 and hired Andy Page, a former president of Gilt Groupe, a shopping website, as its own president. With the goal of testing 1m people, 23andMe launched a national television campaign in August. But seeing little sign of progress with its application, the FDA has called a halt.

It is unclear how the dispute between the FDA and 23andMe will be resolved. In a blog post on November 26th Ms Wojcicki defended the quality of her company’s products but admitted that it was “behind schedule” in its response to the FDA. More rules on gene tests of all sorts are on the way. The cost of sequencing a person’s entire genome has fallen to less than $5,000, from $95m in 2001, according to the National Institutes of Health, America’s medical-research agency. The FDA says it is trying to push things along: on November 19th it approved the first “next-generation” sequencer, made by Illumina, a company from San Diego. Doctors will be able to search patients’ whole genomes to help guide treatment.

Though the FDA talks up progress, there is a risk that it may slow it down. The agency is weighing regulations on test kits sold directly to consumers, laboratory tests and software that analyses raw genetic data. It is clear that 23andMe is not the only testing firm in its sights.